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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: April 24, 2018

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: George H.W. Bush Hospitalized Due to Blood Infection Former U.S. President George H.W. Bush is being treated for a blood infection in a Houston hospital. Bush, 93, was admitted Sunday morning to Houston Methodist Hospital after an infection spread to his blood, spokesman Jim McGrath said on Twitter Monday, the... Read more

Meditation Can Soothe the Anxious Soul in Just One Session

Posted today in Medical

TUESDAY, April 24, 2018 -- A single session of meditation can lower your anxiety levels, a small new study finds. "Our results show a clear reduction in anxiety in the first hour after the meditation session, and our preliminary results suggest that anxiety was significantly lower one week after the meditation session," said study author John Durocher. He is an assistant professor of physiology at Michigan... Read more

Avoid 'Text Neck' From Your Cellphone

Posted today in Medical

TUESDAY, April 24, 2018 -- Your cellphone puts the world at your fingertips, but it can wreak havoc with your neck. There's even a name for the pain you get when looking down at your screen -- "text neck" -- and it can cause problems along the entire length of your spine. Bending your head forward multiplies the amount of weight your neck muscles need to support. Normally your neck supports the 10 pounds that your... Read more

For Soccer Players, Heading May Pose Bigger Risk Than Collisions

Posted today in Medical

TUESDAY, April 24, 2018 -- Heading the ball -- not player collisions -- may lead to temporary thinking declines in soccer players, a new study finds. "Unintentional head impacts are generally considered the most common cause of diagnosed concussions in soccer, so it's understandable that current prevention efforts aim at minimizing those collisions," said study author Dr. Michael Lipton. He is a professor of... Read more

Heavy Drinking Could Raise Your Gum Disease Risk

Posted today in Medical

TUESDAY, April 24, 2018 -- People who drink more than the recommended daily limit of alcohol may harbor an unhealthy mix of bacteria in their mouths, a new study suggests. Researchers found that compared with nondrinkers, those who drank relatively heavily had fewer "good" bacteria in their mouths. They were also hosting more "bad" bacteria -- including bugs that have been linked to gum disease, heart disease and... Read more

Patients Prefer Doctors Who Engage in Face-to-Face Visits

Posted today in News for Health Professionals

MONDAY, April 23, 2018 -- Patients prefer physicians who engage in face-to-face (F2F) clinic visits, rather than those using an examination room computer (ERC), according to a research letter published online April 19 in JAMA Oncology. Ali Haider, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a randomized controlled crossover study involving 120 patients from a... Read more

Controlling High Blood Pressure Could Prevent Dementia

Posted today in News for Health Professionals

MONDAY, April 23, 2018 -- Controlling high blood pressure in older African-Americans may prevent future dementia, according to a study published recently in the Journal of General Internal Medicine. Michael D. Murray, Pharm.D., from the Regenstrief Institute in Indianapolis, and colleagues assessed the longitudinal effects of antihypertensive medications and blood pressure on the onset of incident dementia in 1,236... Read more

Electric Cars Safe With Cardiac Implantable Electronic Devices

Posted today in News for Health Professionals

MONDAY, April 23, 2018 -- Electric cars seem to be safe for patients with cardiac implantable electronic devices (CIEDs), and do not result in electromagnetic interference (EMI), according to a study published online April 24 in the Annals of Internal Medicine. Carsten Lennerz, M.D., from the Technische Universität München in Germany, and colleagues optimized CIED programming to detect EMI according to established p... Read more

Factors ID'd to Predict Fatty Liver in Obese Teens

Posted today in News for Health Professionals

MONDAY, April 23, 2018 -- Ethnicity/race, markers of insulin resistance, and genetic factors might help identify obese youth at risk for developing fatty liver, according to a study published online April 17 in Hepatology. Domenico Tricò, M.D., from the Yale University School of Medicine in New Haven, Conn., and colleagues conducted abdominal magnetic resonance imaging to quantify hepatic fat content, an oral ... Read more

Flexible Sigmoidoscopy Cuts CRC Incidence, Mortality in Men

Posted today in News for Health Professionals

MONDAY, April 23, 2018 -- Flexible sigmoidoscopy screening is associated with reduced colorectal cancer (CRC) incidence and mortality in men, but not women, according to a study published online April 24 in the Annals of Internal Medicine. Øyvind Holme, M.D., Ph.D., from Sørlandet Hospital Kristiansand in Norway, and colleagues conducted a randomized controlled trial involving adults aged 50 to 64 years at baseline w... Read more

FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting

Posted 4 days ago in New Drug Approvals

Lugano, Switzerland April 20, 2018 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of Akynzeo (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing CINV. The FDA has a... Read more

Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy

Posted 5 days ago in New Drug Applications

LONDON and CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW”, “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced that the Peripheral and Central Nervous System Drugs Advis... Read more

FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

Posted 5 days ago in New Drug Approvals

18 April 2018 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The approval is based on results from the Phase... Read more

FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia

Posted 6 days ago in New Drug Approvals

April 17, 2018 -- The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a... Read more

FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia

Posted 7 days ago in New Drug Approvals

SOUTH SAN FRANCISCO, Calif., April 17, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved Tavalisse (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Tavalisse is an oral spleen... Read more

FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures

Posted 12 days ago in New Drug Approvals

April 11, 2018 -- On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal... Read more

FDA Accepts New Drug Application for Duvelisib and Grants Priority Review

Posted 2 weeks ago in New Drug Applications

BOSTON--(BUSINESS WIRE)--Apr. 9, 2018-- Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib. Duvelisib is a... Read more

Antares Pharma Provides Xyosted Regulatory Update

Posted 2 weeks ago in New Drug Applications

EWING, N.J., April 05, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) (the Company) today announced that the U.S. Food and Drug Administration (FDA or the Agency) acknowledged receipt of the Company’s March 29, 2018 resubmission to the Complete Response Letter (CRL) received in connection with the Xyosted (testosterone enanthate subcutaneous injection) New Drug Application. The FDA considered this r... Read more

Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA

Posted 2 weeks ago in New Drug Applications

BOSTON, April 04, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an investigational once-daily oral and intravenous (IV) broad spectrum antibiotic. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment... Read more

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

Posted 2 weeks ago in New Drug Applications

April 4, 2018 - Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. The E... Read more

Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality

Posted 8 days ago in Clinical Trials

TITUSVILLE, N.J., April 16, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that data from a Phase 2 proof of concept clinical study of esketamine nasal spray, published in the American Journal of Psychiatry, showed that treatment with esketamine resulted in a statistically significant, clinically meaningful improvement in depressive symptoms at four hours, including a measure of ... Read more

Inventiva Announces a U.S. Phase II Investigator-Initiated Study with Lanifibranor on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes

Posted 2 weeks ago in Clinical Trials

Daix (France), April 4th, 2018 - Inventiva, a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Dr. Kenneth Cusi, Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida, Gainesville, has selected lanifibranor for a Phase... Read more

Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy

Posted 3 weeks ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., April 3, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys. The trial did not achieve statistical significance for its primary endpoint, which was mean change in proteinuria comparing fostamatinib dose... Read more

Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy

Posted 3 weeks ago in Clinical Trials

Thursday, March 29, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30... Read more

Phase III data in The Lancet Show Novartis Siponimod Significantly Improves Outcomes in Patients with Secondary Progressive MS

Posted 4 weeks ago in Clinical Trials

Basel, March 23, 2018 - Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet. These pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed disability progression with siponimod versus placebo[1]... Read more